(b)(4).Investigation summary: two photos were received by our quality team for evaluation.Upon visual inspection of the photos, the valve was observed to have moved.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of the leakage is due to the moving valve.The appropriate personnel have been notified of this complaint.Bd is aware of this issue and is in the process of implementing corrective actions to improve the customer and patient experience.This event has been added to our complaint database.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: based on the photo returned, the leakage was due to valve moved issue.Capa# (b)(4) has been initiated to address the issue.
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